In the wake of regulatory scrutiny, drug firm Cipla Ltd on Thursday (November 23) reasserted its confidence in its existing commercial product portfolio, stating that it perceives no material risk to its current offerings.
"We once again confirm that we do not see material risk to our existing commercial product portfolio. The Company is in the process of executing the de-risking plan for its new products and simultaneously addressing the observations expeditiously," Cipla said in a regulatory filing.
The pharma major's response comes after the United States Food & Drug Administration (USFDA) made public the warning letter it issued to the company's Pithampur unit on November 20.
CNBC-TV18 has managed to access the warning letter issued which includes the data integrity issues highlighted by the regulator, with product complaints, and microbial contamination.
Additionally, the letter mentions similar and repeated observations at the Goa site. The Goa unit is already under a warning letter from the USFDA.
"We also submit that we uphold quality and compliance with the utmost importance and remain committed to being compliant with the cGMP quality standards. The company is in the process of submitting a requisite response to the warning letter within the stipulated timelines and shall work closely with the USFDA to address the concerns," it said.
The USFDA has asked Cipla to seek the help of third-party consultants to address these issues. Cipla's Pithampur facility was inspected by the USFDA between February 6 and February 17, 2023, post which it issued Form 483 with eight observations. The said plant manufactures respiratory and oral products for the company.
Shares of Cipla Ltd ended at ₹1,168.60, down by ₹103.05, or 8.10% on the BSE.
(Edited by : Ajay Vaishnav)
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